This is a phase II double blind multicenter randomized placebo-controled clinical study aimed to find out whether treatment with Filtrum-STI (orally administered 0,4g tablets) is safe and effective in children with viral gastroenteritis. Filtrum-STI (lignin hydrolytic) is a drug with a high absorbing ability, that binds and eliminates toxins, pathogenic microorganisms and viruses. Filtrum-STI is inoffensive for mucous membranes, enhances colonic propulsion and improves its natural microflora. The drug is not toxic and well combines with other medication

For children aged less than 1 y.o.: Filtrum-STI, 400mg per day (1/2 tablet 2 times a day) for 7 days.

For children aged 1-4 y.o.: Filtrum-STI, 800mg per day (1 tablet 2 times a day) for 7 days.

Other Name: lignin hydrolytic, sorbent, enterosorbent

Placebo Comparator: Placebo

Drug: Placebo

For children aged less than 1 y.o.: Placebo, 1/2 tablet 2 times a day for 7 days.

For children aged 1-4 y.o.: Placebo, 1 tablet 2 times a day for 7 days.

Eligibility

Ages Eligible for Study:

1 Month to 4 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

children aged 0-4 y.o. diagnosed with moderate viral gastroenteritis;

72 h or less from the onset of gastrointestinal symptoms.

Exclusion Criteria:

severe diseases;

individual intolerance of Filtrum-STI

treatment with antiviral, immunomodulatory drugs during the study and 2 weeks before inclusion

treatment with pre- pro- and antibiotics 2 weeks before inclusion

participation in other clinical study 1 month before inclusion and during participation in the study.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01113346